1. Field of the Invention
The present invention relates to a suture sleeve having a gripping enhancing structure. The gripping enhancing structure may be insert molded into a suture sleeve or may be formed integrally with the suture sleeve or attached to the suture sleeve. The suture sleeve is adapted to be secured to a ligated vein or underlying tissue during implantation of a pacing lead body within a body and the gripping enhancing structure facilitates secure fixing of the lead body in the suture sleeve at the time of implantation of the lead.
2. Description of the Prior Art
Heretofore, in the implantation of a pacing lead in an atrium or ventricle of a heart, a surgeon makes an incision at the venous site of choice. Then, a pacing lead is inserted into the right or left cephalic vein or the right external jugular vein near a pocket site chosen for a pacer or pacemaker unit containing a pulse generator. Now a tip electrode of the lead is moved through the vein and into an atrium or ventricle of the heart and fixed in place. After determining that the electrode position is satisfactory, the lead is connected to a pacer unit to be implanted in the pocket.
Next, an elastomeric suture sleeve, which is movable on the lead, is grasped at the tapered end and slid to a location where it is desirable to fasten the lead to tissue or to a ligated vein.
Examples of structures for securing a catheter or lead body to tissue or a ligated vein are disclosed in the following U.S. Patents:
The Reynolds U.S. Pat. No. 3,730,187 discloses a split collar which is C-shaped in cross-section and which has a plurality of sharp teeth or prongs that can grip the outer surface of a catheter when it is adjustably positioned in a desired location. A suture material is embedded within the collar and exits at the opening of the C in the C-shaped collar.
The Riely et al. U.S. Pat. No. 3,821,957 discloses a tubular body having four slits in the tubular body so that four arms can be folded out therefrom to form a retention slide for a catheter or tube.
The H'Doubler U.S. Pat. No. 3,176,690 discloses a catheter having tabs or flanges projecting therefrom which have openings therein for receiving a suture for securing to the skin of a patient.
The Peters U.S. Pat. No. 4,287,891 discloses a surgical safety holding device which is adapted to be fixed externally of a body to the body of a patient and fitted with a body tube. The device is used for securing the body tube against displacement. The device includes two tubular members which are telescoped together, which are rotatable relative to each other and which define a bore therein for receiving the body tube.
The Schiff U.S. Pat. No. 4,122,858 discloses an adapter for use with an intra-aortic balloon or similar device which facilitates insertion and positioning of the device and is designed to fit within a synthetic graft which is sutured, for example, to an artery. An annular groove is provided in the adapter, permitting the graft to be tightly held thereto in the region of the groove, with the device within the graft being able to freely slide therein for enabling proper positioning of the device. An insert is shown in combination with a suture groove. However, the insert is not resilient and only the catheter walls are formed of a resilient material.
As will be described in greater detail hereinafter, the suture sleeve with gripping enhancing structure of the present invention provides a resilient device which, when placed over a pacing lead body, grips the lead body when sutures are applied around the device to keep the device in place on the lead body as well as providing a structure which may be sutured to keep the lead body in place without interfering with the integrity of the lead body.